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皮下注射肝素、静脉注射肝素及阿司匹林治疗不稳定型心绞痛的随机对照研究。难治性不稳定型心绞痛皮下肝素研究(SESAIR)组

Randomised comparison of subcutaneous heparin, intravenous heparin, and aspirin in unstable angina. Studio Epoorine Sottocutanea nell'Angina Instobile (SESAIR) Refrattorie Group.

作者信息

Neri Serneri G G, Modesti P A, Gensini G F, Branzi A, Melandri G, Poggesi L, Rostagno C, Tamburini C, Carnovali M, Magnani B

机构信息

Clinica Medica and Cardiologia, University of Florence, Italy.

出版信息

Lancet. 1995 May 13;345(8959):1201-4. doi: 10.1016/s0140-6736(95)91990-2.

Abstract

Intravenous heparin has been used in the control of myocardial ischaemia in patients with unstable angina. We set out to assess the efficacy of subcutaneous heparin in reducing myocardial ischaemia in patients with unstable angina. 343 of 399 patients with unstable angina were monitored for 24 h and 108 were refractory to conventional antianginal treatment and were entered into a randomised multicentre trial. 37 patients were assigned to heparin infusion (partial thromboplastin time 1.5-2 times baseline), 35 to subcutaneous heparin (adjusted dose with partial thromboplastin time 1.5-2 times baseline), and 36 to aspirin (325 mg daily). All had additional conventional antianginal therapy. After the run-in patients were monitored for 3 days. The primary endpoint was reduced myocardial ischaemia assessed by the number of anginal attacks, silent ischaemic episodes, and duration of ischaemia per day. At 1 week and 1 month we accounted for anginal attacks and other clinical events (myocardial infarction, revascularisation procedures, and death). Aspirin did not significantly affect the incidence of myocardial ischaemia. On the first 3 days, infused and subcutaneous heparin significantly decreased the frequency of angina (on average by 91% and 86%, respectively), episodes of silent ischaemia (by 56% and 46%), and the overall duration of ischaemia (66% and 61%) versus run-in day and aspirin (p < 0.001 for all variables). The favourable effects of heparin therapy remained evident during follow-up. Only minor bleeding complications occurred. Subcutaneous heparin is effective in the control of myocardial ischaemia in patients with unstable angina.

摘要

静脉注射肝素已用于控制不稳定型心绞痛患者的心肌缺血。我们着手评估皮下注射肝素对降低不稳定型心绞痛患者心肌缺血的疗效。对399例不稳定型心绞痛患者中的343例进行了24小时监测,其中108例对传统抗心绞痛治疗无效,进入随机多中心试验。37例患者被分配接受肝素输注(部分凝血活酶时间为基线的1.5 - 2倍),35例接受皮下注射肝素(调整剂量使部分凝血活酶时间为基线的1.5 - 2倍),36例接受阿司匹林(每日325毫克)。所有患者均接受额外的传统抗心绞痛治疗。导入期后对患者进行3天监测。主要终点是通过心绞痛发作次数、无症状缺血发作次数和每日缺血持续时间评估的心肌缺血减轻情况。在1周和1个月时,我们统计了心绞痛发作及其他临床事件(心肌梗死、血管重建术和死亡)。阿司匹林对心肌缺血的发生率没有显著影响。在最初3天,与导入期及阿司匹林相比,输注肝素和皮下注射肝素均显著降低了心绞痛发作频率(平均分别降低91%和86%)、无症状缺血发作次数(降低56%和46%)以及缺血总持续时间(降低66%和61%)(所有变量p < 0.001)。肝素治疗的有益效果在随访期间仍然明显。仅发生了轻微的出血并发症。皮下注射肝素对控制不稳定型心绞痛患者的心肌缺血有效。

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